ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Report
- Report Number
- 3006425876-2022-00553
- Event Type
- Malfunction
- Date Received
- June 17, 2022
- Date of Event
- May 25, 2022
- Report Date
- May 30, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- FOZ
- PMA / PMN Number
- K900263
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4).
QN (B)(4). THE CUSTOMER RETURNED ONE ARROW RAULERSON SYRINGE (ARS) ATTACHED TO AN 18 GA INTRODUCER NEEDLE FOR INVESTIGATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THERE WERE NO CRACKS OBSERVED ON THE NEEDLE HUB. THE ARS TIP APPEARED NORMAL. WHEN COMPARED TO A LAB INVENTORY ARS/INTRODUCER NEEDLE SUBASSEMBLY, THE NEEDLE HUB ON THE COMPLAINT SAMPLE APPEARS TO FIT CLOSER TO THE ARS BARREL. LIKEWISE, ADDITIONAL TESTING OF THE INTRODUCER NEEDLE HUB REVEALED IT DID NOT CONFORM TO ISO 594-1:1986. THE INTRODUCER NEEDLE WAS FUNCTIONALLY TESTED WITH THE RETURNED ARS PER THE INSTRUCTIONS FOR USE (IFU) WHICH STATES, "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." THE RETURNED NEEDLE FELT LOOSE ON THE ARS BUT WAS ABLE TO DRAW AND ASPIRATE WATER WITH NO ISSUES. THE CONNECTION BETWEEN THE RETURNED SYRINGE AND NEEDLE WAS COMPARED WITH A LAB INVENTORY ARS SYRINGE AND INTRODUCER NEEDLE. THE RETURNED ARS SYRINGE WAS TESTED WITH A LAB INVENTORY NEEDLE, AND THE RETURNED NEEDLE WAS TESTED WITH A LAB INVENTORY ARS SYRINGE. THE RETURNED NEEDLE HUB APPEARS TO BE FITTING LOOSELY ON BOTH THE RETURNED SYRINGE AND THE LAB INVENTORY SYRINGE. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS NOT WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER WAS NON-CONFORMING PER ISO 594-1:1986. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND A RELEVANT FINDING WAS IDENTIFIED. FOR MATERIAL K-04300-019A , A NON-CONFORMANCE WAS INITIATED FOR BATCH 71P21G0463 TO ADDRESS THE ISSUE OF A SYRINGE/NEEDLE CONNECTION NOT SECURE. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT STATES THE FOLLOWING: "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." THE REPORTED COMPLAINT THAT THE SYRINGE/NEEDLE CONNECTION WAS NOT SECURE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. THE RETURNED NEEDLE APPEARS TO BE FITTING LOOSELY ON BOTH THE RETURNED SYRINGE AND THE LAB INVENTORY SYRINGE. IT WAS DISCOVERED THAT THE INTRODUCER NEEDLE HUB DID NOT CONFORM TO ISO 594-1:1986. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE FOR THIS ISSUE IS SUPPLIER RELATED. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE.
IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN HAD TROUBLE COMBINING THE SYRINGE AND CATHETER. A NEW KIT WAS OPENED TO FINISH THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN HAD TROUBLE COMBINING THE SYRINGE AND CATHETER. A NEW KIT WAS OPENED TO FINISH THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202342 | ARROW CVC SET: 2-LUMEN 7 FR X 20 CM | CATHETER INTRAVASCULAR THERAPE | FOZ | ARROW INTERNATIONAL LLC | 71F21H0196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |